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FDA Drug Application 009818 by MONARCH PHARMS

Application Number009818
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/27/1955N       
AP011/25/1974SCS       
AP09/27/1976SCS       
AP02/9/1977SCP       
AP04/10/1978SCP       
AP04/10/1978SCE       
AP06/14/1979SCM       
AP02/19/1980SCM       
AP09/3/1982SCP       
AP07/1/2011SLR29436018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009818s018ltr.pdf 7/7/2011
AP07/1/2011SLR29453018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf 7/7/2011




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